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cladribine

Last Updated: December 7, 2017
Result type: Reports
Project Number: SR0546-000
Product Line: Common Drug Review

Generic Name: cladribine

Brand Name: Mavenclad

Manufacturer: EMD Serono, a Division of EMD Inc., Canada

Indications: Multiple Sclerosis, relapsing

Submission Type: New

Project Status: Received

Biosimilar: No

Fee Schedule1: Pending

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Key Milestones2

Call for patient input posted3November 03, 2017
Patient group input closed3December 22, 2017
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Submission receivedDecember 01, 2017
Submission accepted for reviewDecember 15, 2017
Review initiated-
Draft CDR review report(s) sent to applicant-
Comments from applicant on draft CDR review report(s) received-
Redaction requests from applicant on draft CDR review report(s) received-
CDR review team's comments on draft CDR review report(s) sent to applicant-
Canadian Drug Expert Committee (CDEC) meeting-
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans-

Tags

multiple sclerosis, nervous system